11. political and regulatory aspects of veterinary antibiotics use in europe

DS / Zactran Forum ‐ Cascais ‐ 30 Sept 2010 1
3
ANTIBIOTIC
VOLUMES AND
DISTRIBUTION
4
RESISTANCE
MONITORING
5
RESPONSIBLE
USE
Political and Regulatory Aspects of
Veterinary Antibiotic use in Europe
DIETER SCHILLINGER
1
ANIMAL
HEALTH AND
FOOD
SECURITY/
FOOD SAFETY
2
THE WAR OF
« BUGS vs.
DRUGS »

Animal Health and Food Security/Food Safety
• WORLD POPULATION
• FOOD SECURITY/FOOD SAFETY
• RESIDUES

AH – FOOD SECURITY/FOOD SAFETY
Animal medicines incl. antibiotics
have a very important future!
• Saving agricultural resources will be essential for food security
Green et al. (2005) “Farming and the Fate of Wild Nature.” Science
Tilman et al. (2002) “Agricultural sustainability and intensive production practices.” Nature
UN-FAO (2002) “World Agriculture: toward 2015/2030”

A very important future?
• “20% of animal production is lost
because of animal diseases”
Univ.
Leuven
• “Without veterinary medicines we
would need 89% more cattle in
Europe to produce the same amount
of meat and milk”

• Data provided by the 27 EU Member States for 2008
• Over 750,000 targeted meat/milk samples - less than 2,000
(0.27%) results were found to be over the legal limits
• The highest proportion of the non-compliant results:
Antimicrobials (46%)
Hormones (19%)
Other veterinary medicinal products (18%)
• Fact = only 0.12% (46% of 0.27%) of 750,000 samples
contained levels of antibiotics above legal limits.
Animals are not “stuffed full of antibiotics”
EFSA report on residues (2010)

Animals need medicines too!
• The need for antimicrobials to treat
animal bacterial diseases will remain
- Ethical reasons
- Economical reasons
- Environmental reasons
- Food safety reasons

The war of “bugs vs. drugs”
• HISTORY OF ANTIBIOTIC AND RESISTANCE DEVELOPMENT
• EUROBAROMETER
• CRITICAL LISTS OF ANTIBIOTICS

THE WAR OF « BUGS vs. DRUGS »
Resistance is inherent to us
Fleming: Nobel Prize lecture - 1945
“If a specific antibiotic is frequently applied,
selection of resistant individuals among
the target bacteria will normally result”
If a bacterium develops resistance against a
specific antibiotic, other antibiotics of the same
class with a similar mode of action may also lose
their effectiveness (cross resistance).
In 1947 physicians observed the first case of clinical resistance
(Staphylococcus aureus/Penicillin).

THE WAR OF “BUGS vs. DRUGS”
• 20% of Europeans said they had taken ABs to treat flu
• 53% of Europeans said ABs kill viruses
• 83% were aware that the unnecessary use of ABs makes them
ineffective
Eurobarometer (2010)
ECDC Report 2008
Consuming few antibiotics: Dutch (1), Germans, Scandinavians
and Baltics
- 5% penicillin resistance in Streptococcus pneumonia
Main users: Greece (1), Cyprus, France, Italy and Spain
- 25% penicillin resistance in Streptococcus pneumonia

T. ISHIBASHI– 17/01/2008; Brussels
Antibiotic Classification
* Also on the critical list of WHO
Tetracyclines*
Sulfonamides*
StreptograminsPolypeptidesQuinolones*
QuinoxalinesPleuromutilinePhenicols
OrthosomycineLincosamidesPenicillins*
NovobiocineIonophoresMacrolides*
Fusidic AcidFosfomycineCephalosporins*
BicyclomycineRifamycineAminoglycosides*
importanthighly importantcritically important

Antibiotic Volumes
• IFAH-Europe: ANTIBIOTICS & CONTEXT
• MEMBER STATE SYSTEMS
• EMA PROPOSAL - ESVAC

Decreased antibiotic use in animals? –
Yes, sort of!
COLLECTING VOLUME DATA

COLLECTING VOLUME DATA
ESVAC – European Surveillance of
Veterinary Antimicrobial Consumption
• Broad agreement on the value of collecting volume data
(interpretation of AMR monitoring over time).
• The data should be collected in a reliable, efficient,
consistent and verifiable manner yet providing for
confidentiality.
• The cumulative data should be presented in a format that
makes it scientifically useful for researchers, risk assessors
and stakeholders yet balances the level of detail with the
resources necessary to obtain it.
• Data collection together with context data (animal
production, food production, disease prevalence, other
external factors that my influence antimicrobial usage).
• Risk managers should consult with stakeholders in
interpretation of the data.

Antimicrobial Resistance (AMR)
Monitoring
• EU - JOINT OPINION ON AMR/ZOONOTIC INFECTION
• STAFF WORKING PAPER OF THE COMMISSION
• CONSEQUENCES FOR VETERINARY MEDICINE

RESISTANCE MONITORING
AMR challenge today
• Salmonella resistance to Fluoroquinolones & Cephalosporins
• Campylobacter resistance to Fluoroquinolones & Macrolides
• MRSA (Methicillin Resistant Staphylococcus aureus) presence in
swine
• ESBL (Extended Spectrum Beta-Lactamase) in Gram negative
bacteria (most commonly E. coli and Klebsiella pneumoniae)
• Direct transfer from animals to humans via zoonotic pathogens
• In-direct transfer of resistance genes from animal bacteria
non-pathogenic for humans to human pathogenic species

Commission – staff working
paper on AMR (2009)
• Purpose: serve as a basis for discussion and further reflections
• AMR is an unresolved issue in public health
• Each year 25,000 patients die in the EU/costs of 1.5bn €
• Decreasing pace of introduction of new classes of AM
• EARSS (European Antimicrobial Resistance Surveillance System) in human
medicine
• Harmonised monitoring for MRSA on intensively reared animals; AMR of
Campy in poultry; AMR in commensals and ESBL
• Applicants are requested to address the issue of AMR and propose
measures to limit its development
• Recommendations and tools to improve responsible use

Possible consequences
• Prohibition/limitations of veterinary use of certain critically
important antimicrobials for human medicines
• Change of dispensing rights of veterinary medicines from
veterinarians to pharmacies
• Harmonisation of risk assessment methodologies
• Mandatory collection of usage at species level
• Resistance as a pharmacovigilance adverse event
• Prohibition of the advertising of veterinary antimicrobials
• Legal enforcement of responsible veterinary use of antibiotics

• WHAT NEEDS TO BE DONE
• EPRUMA
• CONCLUSIONS

RESPONSIBLE USE
How to address AMR in
humans by vet medicine?
• Reducing the use of antibiotics in vet medicine?
Difficult: 80% of animal medicines are related to infectious
diseases (less than 10% in human medicine)
• New antimicrobial classes/pathogen-specific (narrow-
spectrum/disease-focused) antibiotics
• Alternative means (e.g. probiotics, bacteriophages, efflux pump
inhibitors, biofilm disrupters, virulence factors,)
• New vaccines; state-of-the-art on-site diagnostics
• Responsible use of antibiotics

RESPONSIBLE USE
“Best-practice framework for the use of
antimicrobials in food-producing animals
in the EU” – www.epruma.eu
• COPA/COGECA (farmers and co-operatives),
• EISA (European Initiative for Sustainable Development
in Agriculture),
• FEFAC (feed manufacturers),
• FESASS (animal-health farmer organizations),
• FVE (veterinary surgeons)
• IFAH-Europe (animal health industry)

CONCLUSIONS
Conclusions
• We face a food supply challenge
• Animals need medicine too – we cannot eliminate
diseases
• Innovation needs to be encouraged
• Susceptibility surveillance needs to be harmonized and
volume collection needs to be rolled out
• Responsible use must be promoted
“The right antibiotic applied correctly”
“As little as possible, but as much as necessary”

THANK YOU
A happy end?

11. political and regulatory aspects of veterinary antibiotics use in europe

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11. political and regulatory aspects of veterinary antibiotics use in europe